Events

Retiro De Equipo (Recall) de MAGNETOM Combi Dockable Neurosurgery Table

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Siemens Healthcare Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2016-RN-01360-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2016-10-14
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01360-1
  • Notas / Alertas
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Australia.
  • Notas adicionales en la data
  • Causa
    It has been identified that due to a potential manufacturing error, in some cases a potential exists for a sudden drop in table height. this can happen with or without user interaction. the maximum drop in height is 5cm. it is therefore necessary to verify whether the tables are affected and carry out any required corrections.
  • Acción
    Siemens is requesting that users do not use the system until it has been inspected by a Siemens Customer Service Engineer. Further information about the use of system and the necessary corrections will be provided at the time of inspection. Siemens will contact affected users shortly to arrange a suitable inspection time. This action has been closed-out on 27/02/2017.

Device

MAGNETOM Combi Dockable Neurosurgery Table

Manufacturer

Siemens Healthcare Pty Ltd
  • Empresa matriz del fabricante (2017)
    Siemens AG
  • Source
    DHTGA